A major problem confronting the various makers and users of products made from thermoplastic resins such as telecommunication products, consumer electronic products, automotive parts, medical devices or containers, and identification documents (e.g., identity (ID) cards, credit cards, etc.), has been the unauthorized reproduction or copying of such products or articles by unauthorized manufacturers, sellers, and/or users. Such unauthorized reproduction is often referred to as piracy and can occur in a variety of ways, including consumer level piracy at the point of end use as well as wholesale duplication at the commercial level. Regardless of the manner, piracy deprives legitimate manufacturers of significant revenue and profit. In addition, in many cases, piracy is associated with manufacturer liability. In fact, piracy could tarnish the image of a brand by associating defective counterfeit products with reputable companies.
In the case of the pharmaceutical industry, the consequences of piracy and counterfeiting may be even more severe than in other industries because the health of the patients may be at stake. The growing concerns around that industry attracted the attention of the Federal Drug Administration (FDA) who released a report on February 2004 containing recommendations to fight drug counterfeiting. Similarly, single use devices (SUDs) are also being looked at by the FDA because of the growing number of reprocessed SUDs that are inappropriately being used. Defective or contaminated devices might have catastrophic consequences on the outcome of a surgery. Although actual guidelines or standards for implementing security solutions have not been established at this time, this industry is looking for solutions to authenticate and track original products at various points in the supply chain. For drug containers and medical devices, it is also desirable to have the ability to confirm if an article has been tampered with or used.
Automated identification of plastic compositions is desirable for a variety of applications, such as recycling, tracking the manufacturing source, antipiracy protection, and others. A variety of identification methods of plastic materials are known, including X-ray and infrared spectroscopy and the use of tags in plastic materials, e.g., UV and near-IR fluorescent dyes added to polymers for identification purposes. Fluorescence lifetime of an embedded dye can also be used for the identification purposes. In addition to the use of organic fluorophores, inorganic tracers were used such as yttrium vanadate, zinc sulfide (ZnS) associated to one metal, and organometallic materials.
Tamper evident labels, tapes, wrappers, and seals have been disclosed as a solution to protect drug containers or packages against tampering. Another common way of protecting pharmaceutical containers is the use of special closure systems that cannot be resealed after opening without leaving obvious evidence of tampering for example by including frangible parts in the closure system. Example of other technologies to protect against tampering, re-use, or re-sterilization also include tamper resistant package with an outer shattering layer.
In the case of medical devices such as those used in surgical procedures, a common way of protecting against re-use is to use indicators or labels that are sensitive to sterilization techniques. Another way of protecting devices against use after re-sterilization is to engineer the device so that the conditions of the sterilization will affect the mechanical properties or shape of an essential component rendering the whole device unusable.
There remains a need for articles and methods for determining authenticity and/or for determining if tampering has occurred.